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Donawa Lifescience Consulting (DLC) has extensive experience assisting and representing clients in discussions with the European Medicines Agency (EMEA), as well as with European national regulatory authorities.

Liaison with the relevant central or national authority during the new drug submission process is key to achieving clearance with the minimum delay. We can assist in developing, assembling and reviewing your submission file, and initiate contact with agencies on your behalf. DLC can then be your intermediary should any questions arise or additional data be required.

Meetings are often necessary to discuss significant regulatory and/or development aspects of a new drug product. DLC can attend meetings with agencies to either represent or accompany client companies.

Please contact us to see how we may be able to assist you.